The Over the Counter Hearing Aid Act of 2017 was passed as part of the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017 (FDAR). This law requires the Food and Drug Administration (FDA) to propose a rule that would establish an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation and finalize a rule within 180 days after the close of the comment period. The provisions of the OTC Hearing Aid Act implement major recommendations from the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NASEM).
In 2018, The Academy also teamed up with other members of the hearing health community to draft consensus recommendations for this new class of devices. The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.
The FDA released the proposed rule for regulation of OTC hearing aids on October 20, 2021:
- FDA Proposed Rule: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
The FDA provides 90 days for public comment with a deadline of 1/18/2022. Individuals can submit comments, in addition to organizations and other entities. The link to submit the comments and to access other submitted comments is available with the proposed rule.
The Academy formed a subject matter expert work group of members to analyze the proposed rule and prepare draft comments. The Academy board reviewed and approved final comments, and the Academy submitted the comments to the FDA on December 8, 2021. The FDA has to review and respond to all received comments, so the final rule likely will not be out before late spring.